Kornimate/medical-research-clean huggingface dataset:
mesh fixation in lichtenstein hernioplasty

Conditions: Inguinal Hernia

Summary: this is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. three mesh fixation techniques are compared to find out best technique in local anaesthesia lichtenstein operation. our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional lichtenstein technique.

some 650 patients with inguinal hernia are operated using lichtenstein operation in local anaesthesia. mesh fixation is performed using 3 methods: optilene™ mesh + cyanoacrylate glue (n=200), self-fixing parietex progrip™ mesh (n=200) and non-absorbable sutures with ultrapro™ mesh (n=200). operative time and pain scores, immediate postoperative outcome, quality-of-life and total costs are followed 1, 7, 30 days and 1 and 5 years postoperatively.

Eligibility criteria:
inclusion criteria: * primary or recurrent inguinal hernia * unilateral or bilateral exclusion criteria: * femoral hernia * massive scrotal hernia * allergy to polypropylene * patient's refusal

Keywords: inguinal hernia mesh fixation glue lichtenstein
management of headache disorders: a clinical trial screening for prognostic patient characteristics

Conditions: Headache

Summary: the management of headache disorders is too often based upon trial and error or on personal beliefs and opinions. seldom it is based on scientific arguments. therefore the identification of prognostic patient characteristics is mandatory as this will lead to a more precise referral of headache patients.a prospective cohortstudy is designed to identify these prognostic patient characteristics. after testing, 186 headache patients (migraine, tension type headache and cervicogenic headache) will be randomly allocated to one of two treatment groups. testing includes the fulfillment of questionnaires (headache diagnosis questionnaire, headache inventory questionnaire and the headache impact test) and physical tests (thermal stimuli, cervical spine examination and pressure algometry). treatment groups are a usual care group (administered by a medical doctor) and a usual care plus physio-/ manual therapy treatment. after six weeks of treatment subjects will complete the headache inventory list and the headache impact test a second time. the perceived effect will be registered allowing the distinction between responders (positive effect) and non-responders (no effect or worse). logistic regression-analysis will be used to identify the specific patient characteristics of the responders and the non-responders. secondly the additional value of the physio-/ manual therapy intervention will be examined. follow-up measurements up to 52 weeks are provided.


Eligibility criteria:
inclusion criteria: * dutch speaking * willing to participate * at least 18 years old * combination of headache and neck pain * headache since at least two months and at least twice a month * a combination of migraine, tension type headache and cervicogenic headache exclusion criteria: * clusterheadache * trigeminusneuralgia * peripheral neuropathy * a history with neck surgery * comorbidity with chronic muskuloskeletal pain like fibromyalgia * radicular pain in the upper extremity * osteoarthritis * down syndroom * physio/ manual therapy treatment in the last 12 months for this headache complaint. * the use of prescribed medication (like nsaids and triptans) for this headache complaint during the last two months * pregnancy * red flags as described in the dutch general practitioners headache guideline

Keywords: cervicogenic headache migraine tension type headache
behavioural economics-based incentives in adults with type 2 diabetes pilot study

Conditions: Diabetes Mellitus, Type 2

Summary: a feasibility pilot study of a randomised control trial of adults newly diagnosed with type 2 diabetes to compare the effectiveness of financial and social incentives on healthy lifestyle behaviour.

this is a pilot study of testing the feasibility of the interventions being implemented in our main trial in local settings. adults newly diagnosed with type 2 diabetes without receiving any anti-diabetic medication in hong kong are randomised to compare the effectiveness of financial and social incentives against a control group receiving standard care. the investigators follow participants for 9-months (6-month intervention period and a 3-month post-intervention follow-up period) to assess glycemic control and other health indicators. participants will be randomly assigned to one of two groups (in ratio 3:1): arm a (financial and social incentives in addition to standard care), and arm b (control arm receiving standard care). financial incentives will be framed around loss aversion and the endowment effect. social incentives will include peer competition, and social support. financial and social incentives are to encourage increased physical activity and participants will use a pedometer to track activity. participants are followed for an additional 3-months after the cessation of incentives to assess the sustainability of lifestyle changes.

Eligibility criteria:
inclusion criteria: * chinese adults aged 30-70 years * capable of providing informed consent * resident in hong kong * able to communicate in english or chinese * newly diagnosed with type 2 diabetes within a year according to world health organization guidelines: hba1c ≥ 48 mmol/mol (≥ 6.5%); fasting plasma glucose ≥ 7.0 mmol/l (≥ 126 mg/dl); oral glucose tolerance test (ogtt) ≥ 11.1 mmol/l (200 mg/dl) with symptoms, or on two separate occasions if asymptomatic * hba1c ≤ 7.5% * not taking any medication for glycaemic control * willing to take blood tests * access to a smart phone to track physical activity * physically mobile for duration of the trial exclusion criteria: * already participating in another intervention study * any health condition prohibiting them from completing the 9-month trial, such as history of eating disorder, cancer, serious illness, breastfeeding * medical conditions that can affect hba1c measurements including anaemia, haemoglobinopathies, haemodialysis, iron/b12 deficiency or supplements, chronic liver diseases, splenectomy, rheumatoid arthritis, use of anti-retroviral drugs, ribavirin, or aspirin * intend to receive medication for glycaemic control in the next 6 months * intend to seek private medical treatment for diabetes in the next 6 months
assessment of diagonal branch territory

Conditions: Stable Angina; Unstable Angina

Summary: this study was performed to investigate the anatomical attributes that determine myocardial territory of diagonal branches and to develop a prediction model for clinically relevant branches using myocardial perfusion imaging (mpi) and coronary ct angiography (ccta).

bifurcation lesion is one of the most challenging lesion subsets in the field of percutaneous coronary intervention (pci). despite the recent advances in pci techniques and stent technology, most randomized studies failed to prove the superiority of systematic 2 stenting strategy compared with provisional side branch intervention strategy. a certain amount of ischemic burden is required to achieve the benefit of revascularization over medical treatment. compared with major epicardial vessels, side branches are smaller, more variable in anatomy, supplying less myocardium and less clinically relevant. therefore, it is important to assess the myocardial mass at risk of side branches to determine the appropriate treatment strategy for bifurcation lesions. however, how to define the clinically relevant side branches which can be associated with the benefit of revascularization in a cardiac catheterization laboratory is not well-known. the investigators performed this study to investigate the anatomical attributes that determine ischemic burden and myocardial territory of diagonal branches and to develop a prediction model for a clinically relevant diagonal branch using myocardial perfusion imaging (mpi) and coronary ct angiography (ccta).

Eligibility criteria:
inclusion criteria: * patients with severe jailed diagonal branch disease with available mpi in 3 months (mpi arm) * patients who had available fmm value of diagonal branches from a previous multicenter prospective ccta registry (ccta arm) exclusion criteria: * patients with \>50% stenosis at left anterior descending coronary artery (lad) or left circumflex artery (lcx), regional wall motion abnormality at lad territory (mpi arm) * patients with diffuse diagonal branch disease (ccta arm)

Keywords: bifurcation side branch ischemia myocardium revascularization
modified ramped position for intubation of obese females.

Conditions: Obesity; Anesthesia

Summary: the aim of this work is to investigate the feasibility of using the modified a ramped position for intubation of obese females in comparison to the traditional ramped position.

adequate conditions for endotracheal intubation require appropriate positioning of head and neck. the sniffing position had been described as the most appropriate head position for endotracheal intubation. sniffing position is achieved through two main components: flexion of the neck by 35° (achieved by head elevation) and extension of the head by 15° 2 to have the sternum at the same level of external auditory meatus 34. sniffing position has the advantage of alignment of the three axes: oral, pharyngeal, and laryngeal axes for reaching the optimal laryngeal visualization. in obese patients, it is recommended to put the patient in the ramped position (back-up position with the tragus of the ear is at the level of the suprasternal notch) in addition to the sniffing head-and-neck position. some commercially available pillows were introduced to facilitate laryngoscopy in obese patients such as: troop elevation pillow and rapid airway management positioner. in addition to difficult laryngeal visualization, another problem commonly confronts anesthetists during intubation of obese females; that is impedance of laryngoscopy by large breasts. this problem commonly hinders the intubation process and might lead to serious hypoxia. most of the positions described in literature were concerned with facilitating laryngeal visualization. no position to the best of our knowledge was applied to aid the introduction of the laryngoscope in the presence of large breasts. the investigators hypothesized that using a special pillow to achieve a modified ramped position (by slight extension of the neck) at the beginning of the laryngoscopy would bring the breasts away from the laryngoscope. after successful introduction of the laryngoscope in the oral cavity, the head will be elevated using a head rest to achieve ordinary ramped position if laryngeal visualization was not adequate. the aim of this work is to investigate the feasibility of using the aforementioned modified ramped position for intubation of obese females in comparison to the traditional ramped position.

Eligibility criteria:
inclusion criteria: * female patients * obese (with body mass index above 30 kg per squared meter) * scheduled for surgery under general anesthesia. exclusion criteria: * patients with scars in the face or neck. * edentulous patients. * patients with airway masses.
tranexamic acid in pregnant women undergoing cesarean section.

Conditions: Cesarean Section Complications

Summary: purpose to evaluate the effects of topical tranexamic acid (ta) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section

uterine atony is the major cause of postpartum hemorrhage (pph), accounting for up to 80% of pph cases. pph is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. the aim of the study is to to explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (ta) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (cd), compared with placebo.

Eligibility criteria:
inclusion criteria: * patients who were admitted for an elective or non-emergency cs during labor and exposed to intraoperative bleeding about 800 ml exclusion criteria: * placenta praevia and placental abruption * women with a medical disorder, * placenta accrete, * allergy to ta, and * intraoperative bleeding thanks to causes aside from uterine atony * patients over 40 or who have * pre-existing coagulation disorders, * with a severe medical disorder * allergy to tranexamic acid * refuse to consent

Keywords: cesarean section tranexamic acid postpartum hemorrhage oxytocin
to measure pain perception with electronic pressure algometer of different size probes : a healthy subjects research

Conditions: Pain

Summary: this study was conducted to explore the influencing factors, subjects and testers' evaluation about pain measurement with hand-held pressure algometer with different size probes. methods:100 healthy undergraduate students(50 males and 50 females) were recruited into this study. pain measurement including pressure pain threshold (ppt) and pressure pain tolerance(pto) was carried out by the hand-held pressure algometer with different size probes (from 1cm2 to 0.01cm2) on three different measuring spots in right forearm. we recorded subjects' skinfold thickness, time per test procedure, types of pain perception, receptivity and degree of accuracy as well as testers' level of laborious.

subjects with the following diseases were excluded: known history of chronic disease, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at lactation period .

Eligibility criteria:
inclusion criteria: aged 20 to 30 the right hand is handedness agreed to participate the research not with known chronic disease not taking analgesics within 3 months exclusion criteria: * history of chronic pain psychiatric diseases diabetes mellitus severe cardiovascular diseases kidney or liver diseases alcohol or drug abuse heavy smoker disagree to participate to the research
cognitive rehabilitation in pediatric acquired brain injury

Conditions: Brain Injuries

Summary: acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one of the leading causes of death and disability for children and adolescents. importantly, injuries affecting the brain in childhood or adolescence appear during a time of development when the brain is particularly vulnerable. thus, pediatric acquired brain injury does not only impact cognitive functions at the time of injury or onset of disease, but also cognitive functions that are yet to develop. changes in cognitive function, and in particular executive dysfunction due to acquired brain injury, cause significant real-life disability, yet solid evidence in support of executive functioning interventions for children and adolescents is lacking. in the present study different group-based cognitive rehabilitation interventions will be compared. the aim of the study is to investigate if a group-based "brain training" intervention is able to improve executive function in children and adolescents after acquired brain injury. efficacy will be assessed immediately after intervention, but also six months after the intervention. the project is in line with international research efforts aimed at establishing more knowledge about how children and adolescents with brain injuries respond to cognitive rehabilitation.


Eligibility criteria:
inclusion criteria: * diagnosed with traumatic brain injury, brain tumor or damage by inflammation in the brain * more than 12 months since injury/illness or more than 12 months since ended cancer therapy * evidence of executive dysfunction in everyday life exclusion criteria: * cognitive, sensory, physical, or language impairment affecting the capacity to attend mainstream school and/or complete the training program * pre-injury neurological disease or psychiatric disorder * recently detected brain tumor relapse * unfit for evaluation of outcome (independent evaluation by 2 investigators) * not fluent in norwegian language

Keywords: child rehabilitation psychotherapy, groups
adherence to dolutegravir and outcome

Conditions: HIV

Summary: the main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance). while the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.


Eligibility criteria:
inclusion criteria: * hiv-1 * age over 18 years * information letter signed * art (antiretroviral therapy) with at least 3 active molecules * patients starting treatment with dolutegravir (naïve to antiretroviral treatment, switch, virologic failure) exclusion criteria: * pregnant woman * hiv-2 * patient does not have responsibility for the observance of treatment (disorder of judgment, guardianship, institutionalization) * patient receiving aid incompatible with compliance with the use of electronic pillbox
the reliability of heart rate variability among patients with brain injury as measured by polar rc810xe compared to holter

Conditions: Acquired Brain Injury

Summary: following a brain injury (bi) in addition to all other systems, there can be a failure in the control of the autonomic system activity. heart rate (hr) has its own normal variability. heart rate is controlled by the sympathetic and parasympathetic systems. therefore, monitoring hr variability (hrv) can help us evaluate the balance of the two systems and their efficiency.decrease in hrv was found to be in correlation with death among patients in the acute stage following abi. decrease in hrv is a pre-stage of hr irregularity and ventricular fibrillation.this disturbance can have a great impact on the patients health condition. in addition there was found an inverse correlation between this situation and the rehabilitation outcomes. based on this data there is a great importance in monitoring hrv during rehabilitation among patients following bi while the patients are required to perform physical activity.the aim of this work is to check whether we can replace the traditional way of measuring hr by ekg holter (gold standard) with a more simple,accessible tool-the polar watch. the aim of this work is to check if the data collected from a polar watch is reliable compared to the data collected from an ekg holter.


Eligibility criteria:
inclusion criteria: * brain injury exclusion criteria: * a medical condition which doesn't allow the patient to participate physical activity. * patients that can not be there own legal guardian. * uncontrolled psychomotoric restlessness.

Keywords: heart rate variability acquired brain injury physical activity
feasibility and safety of bile duct clearance by transcystic sphincter of oddi balloon dilatation

Conditions: Cholecystolithiasis; Choledocholithiasis; Surgery

Summary: to investigate feasibility and safety of intraoperative bile duct clearance by sphincter of oddi balloon dilatation via cystic duct at cholecystectomy. primary endpoint: rate of successful bile duct stone clearance (feasibility). secondary endpoints (safety): rate of peri-interventional complications (injury to the common bile duct, bleeding, injury to surrounding organs: stomach, duodenum, liver) and short-term postoperative complications (bile leak, cholangitis, lipasaemia, pancreatitis, pneumonia). duration of procedure. length of hospital stay.

standard approach to address common bile duct stones is endoscopic retrograde cholangiography (erc) with sphincterotomy. those interventions are performed either before or after gallbladder removal (cholecystectomy), thus, requiring at least two interventions. moreover, erc with sphincterotomy is associated with a considerable rate of short and long-term morbidity. the main complications are pancreatitis (2-7%), post sphincterotomy bleeding (1-2%), impaired function of the sphincter with reflux of duodenal content to the bile ducts and a consecutive risk for cholangitis, stone recurrence and even a potential higher risk for cholangiocarcinoma. the aim of this study is to evaluate an alternative surgical approach of bile duct clearance at the time of cholecystectomy. literature of this approach is scarce; however, it has shown a trend to lower postoperative complications if compared to erc. the technique of sphincter of oddi balloon dilatation and bile duct clearance from stones via cystic duct at cholecystectomy has been described in a few case series. these small case series have shown a good success rate of bile stone clearance and low complication rates when applying the balloon dilation technique for smaller stones. the investigators have used this technique in selected cases with good success as well. however, the technique needs to be assessed regarding feasibility and safety in a consecutive group of patients.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature (appendix informed consent form) * patients ≥ 18 years of age * patients with gallbladder stones and known or expected concomitant bile duct stones * bile duct stones ≤ 6mm in size measured by intraoperative cholangiography exclusion criteria: * women who are pregnant * declined consent * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * enrolment of the investigator, his/her family members, employees and other dependent persons * patients with moderate or severe acute cholangitis * patients with moderate or severe pancreatitis
bioavailability of oxymorphone hydrochloride 40 mg extended release tablets under fed conditions

Conditions: Pain

Summary: the purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended release tablets (sandoz) with opana extended release oxymorphone hydrochloride tablets.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on physical exam, nonmedical history or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c * treatment for drug or alcohol abuse * allergy to opiates
prediction of inter-individual differences in the response to morphine versus milnacipran in patients with sciatica

Conditions: Neuropathic Pain

Summary: clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.


Eligibility criteria:
inclusion criteria: 1. patients with moderate to severe chronic neuropathic pain or patients with radiculitis between 18 and 75 years of age. 2. candidates for chronic opioid therapy for nonmalignant pain as determined by treating physician. 3. patients treated with non-opioid analgetics, anti- inflammatory drugs or low opioid dosage (\< 30 mg of oral morphine-equivalents per day). 4. ability to understand the purpose and instructions of the study and to sign an informed consent. - exclusion criteria: 1.diabetic neuropathy 2.pain in upper limbs 3.receiving anti- depressants and/or anticonvulsants 4.pregnant women 5.inability to comply with study protocol. 6.allergy to opioids 7.a diagnosis of raynaud's syndrome 8.history of substance abuse -

Keywords: opioid induced hyperalgesia neuropathic pain opioids sciatica serotonin-norepinephrine reuptake inhibitor (snri)